MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Low Battery (2584)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 3889-28, lot# v847778, implanted: (b)(6) 2011, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 11-oct-2015.Device evaluation conclusion code pertains to both ipg 3058 interstim ll ((b)(4)) and tined lead, 3889-28, interstim ((b)(4)).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported the patient had the ins removed, the patient noted the lead wire snapped in two and they saw that in the cat scan.The patient stated she was suffering from some bladder issues and they were getting worse.The patient decided to get the ins removed instead of getting it replaced.The patient noted the lead wire snapped in two probably a year ago and they had bladder issues probably a year ago in the fall.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Product id 3889-28 lot# v847778 explanted: (b)(6)2017.If information is provided in the future, a supplemental report will be issued.

Event Description

Follow up information received from the healthcare professional (hcp) reported that the patient had multiple health issues that contributed to the bladder irritation that were unrelated to the ins.The cause of the lead breaking was not determined.The ins was removed on (b)(6)2017 due to the battery being at end-of-life and, per the patient¿s choice, it was not replaced due to their health issues.Per operative notes, the ins was removed and the lead cut (with gentle traction on the lead).The lead was able to be grasped and then it snapped fairly easily.The incision was opened up slightly, dissected down, and the lead was able to be removed in its entirety under direct fluoroscopy guidance.The patient was take to recovery in stable condition.There were no further complications reported or anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7616413
• MDR Text Key: 111627505
• Report Number: 3004209178-2018-13801
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 07/03/2018
• Date Device Manufactured: 11/08/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 48